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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00397098 |
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A. The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period. The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.
Condition | Intervention | Phase |
---|---|---|
Anxiety Disorders |
Drug: SR58611A |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A. |
Enrollment: | 257 |
Study Start Date: | November 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For entry into the open phase:
For entry into the double-blind randomized phase:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
Australia | |
Sanofi-aventis Administrative Office | |
Macquarie Park, Australia | |
Chile | |
Sanofi-aventis Administrative Office | |
Santiago, Chile | |
France | |
Sanofi-aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-aventis Administrative Office | |
Berlin, Germany | |
Hungary | |
Sanofi-aventis Administrative Office | |
Budapest, Hungary | |
Italy | |
Sanofi-aventis Administrative Office | |
Milan, Italy | |
Mexico | |
Sanofi-aventis Administrative Office | |
Mexico, Mexico | |
Russian Federation | |
Sanofi-aventis Administrative Office | |
Moscow, Russian Federation | |
Spain | |
Sanofi-aventis Administrative Office | |
Barcelona, Spain |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | LTE5894, EudraCT 2006-002253-71 |
Study First Received: | November 7, 2006 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00397098 History of Changes |
Health Authority: | South Africa: Medicines Control Council; Chile: Instituto de Salud Publica de Chile; France: Afssaps - French Health Products Safety Agency |
Anxiety disorders, Relapse prevention |
Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Anxiety Disorders |
Mental Disorders SR 58611A Adrenergic Agonists |
Neurotransmitter Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists |
Anxiety Disorders Mental Disorders Physiological Effects of Drugs SR 58611A Pharmacologic Actions Adrenergic Agonists |